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MedApps, Inc., DBA Alere Connedt EXHIBIT 02510(k) SUMMARY

PREMARKET NOTIFICATION 510(k) SUMMARYAs required by 21 CER §807.92(c) Li302~

Submitter

510(k) Owner: MedApps, Inc., DBA Alere ConnectOwner/ Operator: 10027842Registration: 3005916763Address: 8767 E. Via De Ventura, Suite 300, Scottsdale, AZ 85258Telephone: 480-305-6323Fax Number: 480-305-6328Contact Person: Kent DicksContact Person Title: CEODate Prepared: December 12, 2012

Device Information

Trade Name: MedApps 2.0 - Remote Patient Monitoring SystemCommon Name: Remote Patient Monitoring SystemClassification Status: Class II per regulations 870.2910Classification Name: Transmitters and Receivers, Physiological Signal,

Radiofrequency (21 CFR 870.2910, Product Code DRG)

A. LEGALLY MARKETED PREDICATE DEVICE

Legallv marketed predicate devices are:K080798 Intel Health Guide PHS6000K040966 Carematix Modified SystemK083862 MedApps 2.0 - Remote Patient Monitoring System

B. INDICATIONS FOR USE

The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring Systemconsists of 1) a cellular communication hub (MedApps' HealthPAL orMobileLink) an over-the-counter device that resides with the end-user(patient), which connects to commercially available FDA cleared accessorydevices, specifically glucose meters, scales, blood pressure monitors,pulse oximeters, and PT/INR monitors and 2) web-based health datamanagement application (MedApps' HealthCOM), that provides access tocollected data stored on a secure host server system.

MedApps Inc., DBA Alere Connect Remote Patient Monitoring devicesreceive and store measurements collected from the described accessorydevices, either wirelessly using short-range radio protocols (e.g.Bluetooth, Zigbee, WiFi, Bluetooth Low Energy (BLE), Fitlinxx Radios) ortethered via cable (e.g. USB3, serial, etc). Regardless of connectivity mode,the MedApps / Alere Connect monitoring devices do not alter theindications for use of the described peripheral accessory health devices.

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MedApps, Inc., DBA Alere Connect EXHIBIT 02510(k) SUMMARY

MedApps/Alere Connect devices indicate successful or failed datareception and transmission with visual and audio feedback using acombination of any of the following: OLED Display, LED Lights, verbalmessages, and/or audio tones/chimes. MedApps/Alere Connect devicesstore collected data and forward/transmit to server for access inHealthCOM via commercially available, FCC compliant, wirelesstelecommunication protocols (including but not limited to cellular GSM,CDMA and WiMax).

Healthcare professionals, clinicians and other authorized personnel canreview the transmitted information within the MedApps HealthCOMsystem, where they can review collected readings, establish parameters toindicate readings exceptions to set thresholds, or trigger Interactive VoiceResponse (IVR) messages to the patient remotely to issue informationsuch as reminders (e.g. "We haven't received readings from you today,please take and send your readings") or possibly educational informationfor conditions such as diabetes, hypertension, CHE, etc. Additionally,HealthCOM can port collected data to the healthcare providers' clinicalback-end system(s) of choice.

The MedApps 2.0 (Alere Connect) - Remote Patient Monitoring System isnot intended for diagnosis or as a substitute for medical care, nor is itintended to provide real-time / time-critical data. The device iscontraindicated for patients requiring direct medical supervision oremergency intervention.

C. MedApps 2.0 SYSTEM DESCRITPION

The MedApps 2.0 - Remote Patient Monitoring System consists of:

(1) HealthPAL hardware:

The physical component of the l-ealthPAL is an electronic device containedin a plastic enclosure with an OLED screen, built-in M2M cellular chip,speaker, smart cable connection, smart cables, wireless module, LEDlights to indicate activity, timer button to assist patients with their readingschedule (i.e. remind them to take their reading in X minutes), lastreading button, volume up and down buttons. The HealthPAL Model 105contains a GSM cellular module while the HealthPAL Model 106 contains aCDMA cellular module.

(2) HealthHUB hardware / software:

The HealthHUB hardware is an extension of the HealthPAL functionality.HealthHUB acts as a "docking" station for the H-ealthPAL in order to act asa conduit for the AC power adaptor connecting the electrical wall outlet tothe HealthPAL providing power and battery charging capability. The Hubsalso provide additional connections to off the shelf Glucose Meters, Scales,Blood Pressure Monitors and Pulse Oximeters, via smart cables (pervalidated in HealthPAL software). The HealthHUB model MA200 allows formultiple wired connections for accessory devices. HealthHUB Model 205 isspecific for the HealthPAL MAlOS, and the HealthHUB 206 is specific forthe HealthPAL MA 106 with both Hubs having one wired connector.

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(3) H-ealthPAL firmware / software:

The firmware captures d -ata from commercially available health monitors,and stores and transmits the information to the H-ealthCOM server, via theembedded communication chip / platform.

The firmware allows HealthPAL to receive information via wire or viaembedded wireless module from accessory medical devices that arecompatibly wireless enabled, which have been paired to the MedAppsHea Ith PAL.

The firmware has many additional functions including:* Download of user profiles from the server to configure HealthPAL

remotely.* HealthPAL has audio capability to deliver verbal announcement of

readings and acknowledgment of data transmission from allconnected accessory medical devices, time settings, volumecontrol, educational content and reminders, in any language that isloaded to the device.

* Timer capability, activated by the user to provide assistance withadhering to a reading schedule (reminders to take readings withina set timeframe).

* OLED screen displays information regarding the HealthPAL's statusincluding battery level, volume level, data transmission status,transmission pending indicator, activity icons / messages and otherinformation to provide ease of use and promote patient adherence;as well as information received from accessory medical devices,such as the type of device, measurement, date and time of the lastreading collected.

* Battery charging, isolation circuits, and interfaces to individualaccessory medical devices / protocols via the smart cable.

(4) MobileLink (formally HealthAIR) hardware / software:

ACO2O MobileLink is a modified MA1O5 HealthPAL device. The physicalcomponent of the MobileLink is an electronic device contained in a plasticenclosure with built-in 11211 cellular chip, speaker, standard USB cable andUSB Smart Cable connection, OLED screen to review the reading, and LEDlights to indicate activity regarding the receiving and transmitting ofcollected data.

Like the HealthPAL, MobileL-ink's firmware / software captures, data fromcommercially available retail health monitors, and stores and transmitsinformation to the HealthCOM server, via the embedded communicationchip / platform.

The firmware allows MobileLink to receive information via wire, eitherstandard USB or with a customized USB Smart Cable, from accessorymedical devices.

The firmware has many additional functions including:* Download of user profiles from the server to configure MobileLink

remotely.* MobileLink's Audio feature uses audio tones to indicate

acknowledgment of collected readings from all connected accessoryPage ExhibitO2-3

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MedApps, Inc., OBA Alere Connedt EXHIBIT 02510(k) SUMMARY

medical devices as well as reading transmission via the cellularnetwork.MobileLink's visual user interface utilizes an OLED display to displaycollected readings from attached accessory medical devices as wellas reading transmission acknowledgements. MobileLink's visualinterface also contains a LED light to show power and providereading request indication capability.

(6) MedApps HealthCOM software application:

The HealthCOM software application allows caregivers access to reviewpatient data collected from accessory medical devices using MedAppshardware on the secure HealthCOM welbsite. HealthCOM software allowsprofessional caregivers to set patient readings.

HealthCoM software also allows the patient to establish an account and todirect / authorize their data to be directed to an outside, validatedPersonal Health Record (PHR), Electronic Health Record or Medical Record(EHR or EMR).

(7T) MedApps IVR software application:

The IVR (Interactive Voice Response) software application provides theability to contact the patient remotely, by phone (designated in the userprofile), and executes an pre-approved ("canned") scripts to deliver pre-approved ("canned") reminder messages ("Your nurse would like to talk toyou, can I connect you now", "We haven't received a reading from youtoday, please send us your readings"), educational content and gathersurvey information.

In addition, the MedApps IVR application will send out Email, SMS / TextMessages, Paging, IM and other forms of communications in order tocontact patients or caregivers. This will include reminders and alerts,based on clinically defined parameters / thresholds established inHealthCOM by the professional care provider.

The MedlApps 2.0 - Remote Patient Monitoring System is not intended fordiagnosis or as a substitute for medical care, and it is not intended toprovide real time data. The data is made available to the patients whentime-critical care is not required. The device is contraindicated forpatients requiring direct medical supervision or emergency intervention.

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D. TECHNOLOGICAL CHARACTERISTICS SUMMARY - as required by807.92(a)(6)

Feature Intel Health Carematix MedApps MedApps 2.0Guide PHS600O Modified System Submission Submission

K080798 K040966 K083862 K124000

Indications of Use Enables Physiological The MedApps Same ashealthcare monitoring 2.0 - Remote MedApps withproviders to system that Patient the exception ofmonitor and collects, Monitoring updates tomanage chronic accumulates and System consists includeconditions of transmits patient of a MobileL-inkpatients remotely vital isgnes and device and

other patient device, PT/INR monitorsphysiological data MedA ppsfrom a patient H ealthPAL ....who may beremote form the

Intended Use Telemedicine Telemedicine Telemedicine Same asSystem System System PHS6000,

Carematix, andMedApps

Intended Users Home users and Same Same SameHealthcareproviders

Site of Use Home & Clinic Same Same Same

Home Home(HealthPAL) (HealthPAL/Clinic Mobilet-ink);(HealthCOM) Clinic

(HealthCOM)

Data Collection Intel Care Proprietary MedApps MedAppsSoftware Management Software Proprietary Proprietary

Suite Software Software Software

Data Collection Transmit data Same Same SameSoftware from SensorFunctionality devices to Central _________________

Communication Via DSL or Phone Via modem over Via Embedded Via Embeddedmethod of hub Line Connection telephone line Cellular Cellularwith Central Technology TechnologyServer

Types of sensors Medical Devices Medical Devices Medical Devices Same aswhich can be designed for designed for designed for MedApipsinterfaced (wired Home: Home use: Home use: (Glucose, Scale,or wirelessly) to Glucose Glucose, Scale GlucoseScale BP, Pulse Oxreceiver hub Scale Blood Pressure Blood Pressure with PT/INR)

Blood Pressure Pulse Ox, Pulse OxPulse Ox FEX/PEF,PT/INR Same asPeak Flow Temperature CareMatix

Maximum number Determined by Same Same Sameand type of vital sign devicesmeasurement that are designeddevices that can for Home use, andbe connected to have a data port.the devices (Wireless or

Wired)

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Feature Intel Health Carematix MedApps 2.0 MedApps 2.0Guide PHS6000 Modified System Submission Submission

K080798 K(040966 K(083862 K(124000

Maximum data Multiple readings Same Same Samethroughput under are stored on theworst case medical devicesconditions and act as a

backup if dataneeds to be re-sent to the server

Time Delay in the Readings stored Same Same Sameprocessing of data in the medicalcollected and devices can betransmitted sent up to the

server when theconnection isrestored.

Implementation Short range radio Modify OTS Short range Short rangemethod of system using sensors with radio system radio systemcollecting data Wireless previous 510k using Wireless using Wiredfrom sensors (Bluetooth) and approval by (Bluetooth) and (tethered)

Wired (tethered) adding Wired (tethered)cables. communications cables.

Sensor Software Sensor Software Same Same Sameunchanged

Connectivity Short range radio Wired or wireless Short range Short rangesystem using to hub radio system radio systemBluetooth and using Bluetooth using WiredWired (tethered) and Wired (tethered)cables, (tethered)

cables.

Communication Short range radio Wireless RF Short range Short rangemethod of hub system using protocol radio system radio systemwith devices Bluetooth and using Wireless using Wired

Wired (tethered) (Bluetooth) and (tethered)cables, Wired (tethered)

cables.

Communications Bluetooth V2.0 Proprietary~ Wireless Wired (Tethered)Protocol and (Bluetooth) V2.0

Wired (Tethered) and Wired(Tethered) _________

Communication Bluetooth :2.402 915 MHz FCC Bluetooth (HealthPAL orFrequency to 2.480 GHz assigned channel 2,402 to 2,480 MobileLink)

GHz GSM: 850 /900(HealthPAL) / 1800 / 1950GSM: 850 / 900 Mhz/ 1800 / 1950Mhz

Power Source Wall power plug Wall power plug Wall power plug Wall power plug(120 VAC/50-60) (120 VAC/50-60) (120 VAC/50-60) (120 VAC/S0-60)

and Batteries in or Rechargeable or RechargeableDevice Battery Battery

(HealthPAL) (HealthPAL orMobileLink)

Display On devices and Same Same Samehub, and monitorsconnected tocentral server

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MedlApps, Inc., DRA Alere Connedt EXHIBIT 02510(k) SUMMARY

Communication On screen display Same On screen On screenwith Patients display of display with

Readings, Voice audio tonesOutput and instead of voice.Interactive Voice

Use of Thresholds Thresholds are set Same Same Same/ Algorithms for by Healthcaredetermining how professionals inThresholds are set Server Softwareand changed

Information On screen display Same Audio/visual Visual readingpresented to the reading feedback onuser, if it is feedback on screen and audiodifferent from screen and by tone by speaker;that presented by speaker; and and Interactivethe measurement Interactive Voice Voice Responsedevices Response (IVR) (IVR) System for

System for patient contactpatient contact

Messages and On screen display Same On screen On screenInstructions that display of display ofcan be sent to the Readings, Voice Readings, VoiceUser. Output and Output and

Interactive Voice Interactive VoiceResponse (IVR) Response (IVR)

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Below is a Technological Characteristics Summary Comparison between the MA1O5HealthPbAL and the ACO2O MobileL-ink medical devices:

Feature MA105 HealthPAL AC020 MobileLink

Indications of Use Enables healthcare providers to Samemonitor and manage biomnetircpatient data collected remotely

Intended Use Telemedicine System Same

Intended Users Home users and patients outside Sameof the clinical setting, as well asHealthcare providers forflea lthCOM

Site of Use Remote setting (e.g. Home I SameWork), Clinic

Data Collection MedApps Proprietary Software SameSoftware & firmware

Data Collection Transmit data from Sensor SameSoftware Functionality devices to Central Database

Communication method Via Embedded Cellular Sameof device hub with Technology (GSM or CDMA)Central Server

Types of sensors which Medical Devices designed for Samecan be interfaced (wired Home use:or wirelessly) to Glucose, Scale, Blood Pressurereceiver hub Pulse Ox (adding PT/INR with this

submission)

Transmission Transmits information to the SameMedApps secure host servercalled "HealthcoM"

Implementation method Short range radio system using MobileLink uses wired/of collecting data from Wireless (Bluetooth) and Wired / tethered connection (USS,sensors and general tethered (Smart Cables). Smart Cables)Connectivity

Communication method Short range radio system using MobileLink uses wired/of hub with devices Wireless (Bluetooth) and Wired / tethered connection (USB,

tethered (Smart Cables). Smart Cables)

Communication Bluetooth :2,402 to 2.480 0Hz No Bluetooth capabilityFrequency GSM: 850 /900 /1800 / 1950 GSM: 850 /900 /1800/

Mhz 1950 Mhz

Power Source AC adaptor Wall power plug (120 AC Adaptor that is 60601-1VAC/50-60) and Rechargeable 3"d Edition compatible withBatteries in Device Lithium battery only used for

soft shut down functionalityand not powering device.

Device Communication On screen display and audio voice On screen display with audiowith Patients feedback tones instead of voice.

Certification Testing Safety 60601-1, EMC/EMI/FCC Safety 60601-1 3 6d Edition,(60601-1-2), ESO & Radiated EMC/EMI/FCC (60601-1-2),Immunity, FCC Bluetooth, ESD & Radiated Immunity,(PTCRB), CTIA (battery), ETSI (PTCRB- in process), ETSI

(See Declaration of______________________ _________________________ Coformity)

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Data Collection:The 2 predicate devices and the MedApps solution connect to medicaldevices (designed for home use) by either wired (cable) connection orwireless (HealthPAL- Bluetooth). The data is collected from the devicesand sent to a secure central server using various communication methods.

Telecommunication Platform to Central Server:Intel Health uses DSL connectivity (wired point of care), Carematrix usesmodem off telephone line; MedApps uses embedded Machine to Machine(M2M) module to transmit data via cellular connectivity.

Patient Feedback Technology:The 2 predicate devices and the MedApps solution allow data andmessages to be displayed on a screen (for the HealthPAL) for the patientto read and acknowledge. MobileL-ink also uses audio and visualacknowledgement / feedback. The MedApps solution also uses anInteractive Voice Response (IVR) system in order to communicate with thepatient and ask questions, gather survey information, or issue reminders.

Backend Data Storagie:All systems (both 2 predicate devices and the MedApps solution), providea backend system that allows data to be stored, and healthcareprofessionals to access and monitor collected patient data.

Types of sensors which can be interfaced (wired or wirelessly) toreceiver hub:CareMatix Modified System and the proposed MedApps 2.0 System bothinclude PT/INR monitor as an FDA cleared accessory device to the receiverhub. The CareMatix uses wireless connectivity to the hub whereas theMedApss 2.0 systems uses both wired and wireless connectivity to thehub. CareMatix System 510k (K040966) clearance summary letterincludes the predicate Avid Care (1(011779 and K(010029) telemedicinesystem that connects to PT/INR monitor as an accessory device.

E. NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - asrequired by 807.92(b)(1)

Non-Clinical TestingThe submitted 2.0 System has undergone MedApps' design controlverification and validation testing. MedApps 2.0 validation testing includetesting of all executable code and functionality and confirmation that allidentified risks have been adequately addressed by software functionality,the user interface, documentation or user SOP.

MedApps 2.0 System verification and validation activities as part of thedesign control process include testing of all Design Specifications (DesignControl Inputs) based on risk analysis, certification standards, andVerification plans. MedApps Product Verification and Release Planexecution on both HealthPAL and MobileL-ink ensure both medical deviceswork with each type of user accessory medical device (glucose, bloodpressure monitor, scale, pulse oximeter and PT/INR) as part of theMedApps 2.0 System including integration to HealthCOM backend softwareapplication. The output of these design control verification analysisdocuments MedApps 2.0 - Remote Patient Monitoring System shallmeet its requirements and design specifications as intended.

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Lastly, all relevant certification testing such as EMC (60601-1-2) and

Safety (60601-1) are described in MedApps' Declaration of Conformity.

F. SUBSTANTIAL EQUIVALENT

The MedApps 2.0 Remote Patient Monitoring System is substantiallyequivalent to the predicate devices in terms of data collection softwarefunctionality, operating system for the patient device, communicationmethod of patient device with central server, types of sensors which canbe integrated to the patient medical device, implementation methods ofcollecting data from sensors, sensor software, connectivity,communication protocol, power source and general display method.

The MobileL-ink (formally called HealthAIR communication hub device,described in 510(k) K112559) is substantially equivalent to the HealthPAL(described in 510(k) K083862) as both devices, as part of the MedApps2.0 System, connect to commercially available Glucose Meters, Scales,Blood Pressure Monitors, Pulse Oximeters, and PT/INR; data is collected,stored and transmitted using off-the-shelf FCC approved wireless / cellularconnectivity. Both provide audio and visual feedback / acknowledgementthat readings have been collected and transmitted to MedApps' securehost server called "HealthCOM".

G. SAFETY AND EFFICACY

The MedApps 2.0 Remote Patient Monitoring System does not rely on anassessment of clinical performance data. The device conforms to FDA'srecognized consensus standards and relies on its conformity todemonstrate its safety and efficacy. The device does not introduce anynew questions concerning the safety or efficacy and is, therefore,substantially equivalent to the predicate devices.

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oDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

I4 Food and Drug Administration10903 New Hampshire AvenueDocument Control Center - W066-0609Silver Spring, MD 20993-0002

July 30, 2013

MedApps, Inc. OBA Alere ConnectC/O Mr. Kent E. DicksCEO8767 E. Via De Ventura, Suite 300Scottsdale, AZ 85258

Re: K124000Trade/Device Name: MedApps 2.0 Remote Patient Monitoring SystemRegulation Number: 21 CFR 870.29 10Regulation Name: Transmitters and Receivers, Physiological Signal, RadioifrequencyRegulatory Class: Class 11Product Code: ORGDated: January 18, 2013Received: July 3, 2013

Dear Mr. Kent E. Dicks:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act.

The general controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CORN does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You must

Page 2 -Mr. Kent E. Dicks

comply with all the Act's requirements, including, but not limited to: registration and listing (21CER Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of nmedicaldevice-related adverse events) (21 CER 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CER 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet addresshtto)://www.fda.Rov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please notethe regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go tohttp)://www.fda.gov/MedicalDevices/Safetv/ReoortaProbleml/dcfault.html for the CDRH' s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7 100 or at its Internet addresshttp://www.fda.aov/MedicalDevices/ResourcesforYou/industry/default.html.

Sincerely yours,

Owen P. Earls -Sfor Brain D. Zuckerman, M.D.

DirectorDivision of Cardiovascular DevicesOffice of Device EvaluationCenter for Devices andRadiological Health

Enclosure

K12400DPage 1 of 1

MedApps, Inc., DBA Alere Connedt EXHIBIT 01STATEMENT OF INDICATIONS FOR USE

510(k) Number: K124000_____________

Preparation Date: December 12, 2012

Device Name: MedApps (Alere Connect) 2.0 - Remote Patient MonitoringSystem

Indications For Use:

The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) acellular communication hub (MedApps' HealthPAL or MobileLink) an over-the-counterdevice that resides with the end-user (patient), which connects to commerciallyavailable FDA cleared accessory devices, specifically glucose meters, scales, bloodpressure monitors, pulse oximeters, and PT/INR monitors and 2) web-based health datamanagement application (MedApps' HealthCOM), that provides access to collected datastored on a secure host server system.

MedlApps Inc., OBA Alere Connect Remote Patient Monitoring devices receive and storemeasurements collected from the described accessory devices, either wirelessly usingshort-range radio protocols (e.g. Bluetooth, Zlgbee, WiFi, Bluetooth Low Energy (BLE),Fitlinxx Radios) or tethered via cable (e.g. USE, serial, etc). Regardless of connectivitymode, the MedlApps / Alere Connect monitoring devices do not alter the indications foruse of the described peripheral accessory health devices.

MedApps / Alere Connect devices indicate successful or failed data reception andtransmission with visual and audio feedback using a combination of any of the following:OLED Display, LED Lights, verbal messages, and / or audio tones / chimes. MedApps /Alere Connedt devices store collected data and forward / transmit to server for access inHealthCOM via commercially available, FCC compliant, wireless telecommunicationprotocols (including but not limited to cellular GSM, CDMA and WIMax).

Healthcare professionals, clinicians and other authorized personnel can review thetransmitted information within the MedApps HealthCOM system, where they can reviewcollected readings, establish parameters to Indicate readings exceptions to setthresholds, or trigger Interactive Voice Response (IVR) messages to the patientremotely to issue Information such as reminders (e.g. "We haven't received readingsfrom you today, please take and send your readings") or possibly educationalInformation for conditions such as diabetes, hypertension, CF-F, etc. Additionally,HeaithCOM can port collected data to the healthcare providers' clinical back-endsystem(s) of choice.

The MedApps 2.0 (Alere Connedt) - Remote Patient Monitoring System Is not intendedfor diagnosis or as a substitute for medical care, nor is it intended to provide real-time /time-critical data. The device Is contraindlicated for patients requiring direct medicalsupervision or emergency Intervention.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CORN, OfftIce or Device Evaluation (ODE)

Prescription Use______ OR Over-The-Counter Use X(Per 21 CFR 801.109) Digitally signed by

A - Owen P. Faris -S( ~. Date: 2013.07.30Page Exhlbitl1-1 09:07:15 -04'00'

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